FDA.reportPublic FDA data

Absolute Polishers™

Primary DI
10810000526038
Brand
Absolute Polishers™
Company
PARKELL, INC.
Model
S083
Catalog number
S083
Device description
Absolute Polishers™; Cup Smoothers (non-diamond)
Published
2019-08-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJQWheel, Polishing Agent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJQWheel, Polishing AgentDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810000526038PrimaryGS10
00810000526031Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081000052603810810000526038
00810000526031008100005260318100005260310810000526031

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive point, single-useA sterile rotary endpiece designed to be attached to a dental power tool handpiece to perform a specific rotating mechanical function during a dental or orthodontic procedure, typically for polishing and smoothing natural or restorative dental materials (e.g., to finish a crown). Also referred to as a polisher, it is available in various forms [e.g., conical] and sizes and is made of synthetic polymer materials (e.g., silicone, rubber). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dark, dry-humidity environment
Storage Environment Temperature2 Degrees Celsius28 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
6312491134customerservice@parkell.com

Regulatory Flags#

DUNS number
009900424
Device count
24
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810000525782HyperFIL®S235SPS235SP2025-09-26
00810000528271TriPhasix™S408S4082025-09-26
0081000052669720/20™S575S5752025-09-26
00810000522934DuraTip®DURA30-PSLDURA30-PSL2025-07-18
00810000522941DuraTip®DURA30-PSRDURA30-PSR2025-07-18
00810000525751HyperFIL®S236S2362025-03-28
00810000525768HyperFIL®S237S2372025-03-28
00810000525775HyperFIL®S238S2382025-03-28
10810000520319Integra™D681D6812018-11-16
00810000521579PureClarity™D719D7192024-12-13
00810000521647PureClarity™D718D7182024-12-13
00810000525744OTCS833S8332024-06-28
10810000525086Dryz™S180S1802018-09-21
00810000525720HyperFIL®S234S2342024-03-01
00810000525737HyperFIL®S235S2352024-03-01
1081000052758520/20™S475S4752019-08-30
10810000524409Cinch™S469S4692019-07-26
10810000524416Cinch™S470S4702019-07-26
10810000524133Mach-2®S433S433S2018-10-19
10810000524157Blu-Mousse®S437SS437S2018-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630243636051KENDADent4You AGEJQ2025-09-17
07630243636075KENDADent4You AGEJQ2025-09-17
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07630243636105KENDADent4You AGEJQ2025-09-17
07630243636112KENDADent4You AGEJQ2025-09-17
07630243636099KENDADent4You AGEJQ2025-09-17
07630243641406KENDADent4You AGEJQ2025-09-17
07630243641413KENDADent4You AGEJQ2025-09-17
07630243636068KENDADent4You AGEJQ2025-09-17
07630243636228KENDADent4You AGEJQ2025-09-17
07630243636235KENDADent4You AGEJQ2025-09-17
07630243636242KENDADent4You AGEJQ2025-09-17
07630243636259KENDADent4You AGEJQ2025-09-17
07630243636273KENDADent4You AGEJQ2025-09-17
07630243636280KENDADent4You AGEJQ2025-09-17
07630243636266KENDADent4You AGEJQ2025-09-17
07630243641727KENDADent4You AGEJQ2025-09-17
07630243637225KENDADent4You AGEJQ2025-09-17
07630243637232KENDADent4You AGEJQ2025-09-17
07630243637249KENDADent4You AGEJQ2025-09-17
07630243637256KENDADent4You AGEJQ2025-09-17
07630243637362KENDADent4You AGEJQ2025-09-17
07630243637379KENDADent4You AGEJQ2025-09-17
07630243637386KENDADent4You AGEJQ2025-09-17
07630243637393KENDADent4You AGEJQ2025-09-17
07630243642052KENDADent4You AGEJQ2025-09-17
07630243642069KENDADent4You AGEJQ2025-09-17
07630243636709KENDADent4You AGEJQ2025-09-17
07630243636716KENDADent4You AGEJQ2025-09-17
07630243636730KENDADent4You AGEJQ2025-09-17